FDA Adverse Event Malfunction Summary report: N

DELTAFILL10 3MM X 8CM

MDR report key: 8097571 · Received November 21, 2018

Report

Report Number: 3008114965-2018-00797
Event Type: Malfunction
Date Received: November 21, 2018
Report Date: November 6, 2018
Manufacturer: SEE H.10
Product Code: KRD
UDI-DI: 10886704077046
PMA / PMN Number: K150319
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. DATE OF EVENT: THE EVENT OCCURRED IN 2018, HOWEVER, THE MONTH AND DATE OF THE EVENT WERE NOT REPORTED. PRO CODE IS KRD/HCG. (B)(4). INITIAL REPORTER INFORMATION SUCH AS FACILITY NAME, ADDRESS, AND THE NAME, PHONE AND EMAIL ADDRESS ARE UNKNOWN. THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO DETACH THE DELTAFILL 10 3MM X 8CM COIL (DLF100308 / LOT# NOT AVAILABLE) BUT THE COIL DID NOT DETACH; IT WAS ALSO REPORTED THAT DURING THE ATTEMPT TO DETACH THE COIL, MOVEMENT WAS CREATED IN THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
935389	DELTAFILL10 3MM X 8CM	NEUROVASCULAR EMBOLIZATION DEVICE	KRD	SEE H.10			10886704077046

Patients

Seq	Age	Sex	Outcome	Treatment
1